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Acupuncture Therapy for Sudden Sensorineural Hearing Loss

NCT07575334 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2026-05-08

No results posted yet for this study

Summary

The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). The main questions it aims to answer are:

Does acupuncture combined with corticosteroids improve hearing recovery (pure tone audiometry, PTA) at 8 weeks compared with sham acupuncture combined with corticosteroids? Does this treatment improve secondary outcomes, including tinnitus, dizziness, sleep quality, anxiety, and quality of life? Researchers will compare acupuncture (experimental group) with sham acupuncture (control group) to determine the added therapeutic effect of acupuncture.

Participants will:

1. Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks.
2. Meanwhile, take oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper.
3. Undergo hearing tests (PTA, word recognition scores), vestibular function tests, and complete validated questionnaires (SF-36, HADS, ISI, DHI, THI, and TCM symptom scales) at baseline and weeks 1, 2, 4, 8, and 12.
4. Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.

Conditions

  • Sudden Sensorineural Hearing Loss (SSNHL)

Interventions

PROCEDURE

Acupuncture

Main Acupoints (Fixed): Tinghui (GB2), Yifeng (SJ17), Tinggong (SI19), and Shuaigu (GB8) on the affected side; Baihui (GV20) at the vertex; Zhongzhu (SJ3) and Zulinqi (GB41) bilaterally. Adjunct Acupoints (Bilateral, selected based on TCM pattern differentiation): External Pathogen Invasion: Hegu (LI4) + Waiguan (SJ5) Liver Fire Harassing Upper: Yanglingquan (GB34) + Xingjian (LR2) Phlegm Fire Stagnation: Fenglong (ST40) + Neiting (ST44) Qi Stagnation and Blood Stasis: Xuehai (SP10) + Taichong (LR3) Kidney Essence Deficiency: Taixi (KI3) + Sanyinjiao (SP6) Spleen and Stomach Deficiency: Zusanli (ST36) + Qihai (CV6)

PROCEDURE

Sham acupuncture

The same acupoints are used, but with blunt-tip placebo needles that do not penetrate the skin. The needles are fixed with adhesive patches, and the procedure is identical to the real acupuncture group to maintain blinding.

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07575334 on ClinicalTrials.gov